Innovative Compounding Pharmacy Recalls MIC-8 Injectable Due to Sterility Concerns
Innovative Compounding Pharmacy is recalling MIC-8 injectable vials because the firm cannot assure the product's sterility. Patients in California, Maine, and Texas should stop using the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility in an injectable) corresponds to a score of 4 (Severe), as it is not explicitly Class I but involves a serious potential hazard.
Plain-English summary
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy is recalling MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml), a 10 mL injectable prescription product. The recall was initiated because the firm lacks assurance of the product's sterility.
The affected product includes Lot # 03022020@64, which expires after 05-18-2020, and Lot # 01032020@51, which expires after 04-02-2020. The distribution list indicates that the product was shipped to patients in California, Maine, and Texas.
Patients who have received this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 03022020@64
- Expires after 05-18-2020
- Lot # 01032020@51
- Expires after 04-02-2020
Distribution
Part of a larger recall action
This product is one of 5 recalled by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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